Aktuelle Jobs im Zusammenhang mit Regulatory Affairs - Zurich - Proclinical

  • Head Regulatory Affairs Emerging Markets

    vor 2 Wochen

    Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    **People First** - At Takeda we are dedicated to improving the health and well-being of all people and bringing them the hope of a brighter future. It is our passion that transforms every job into meaningful action. **Our people are the heart of Takeda**. Are you a strategic and visionary leader with a strong background in regulatory affairs within the...

  • Regulatory Affairs Manager Pharma Eu/ch

    vor 1 Woche

    Zurich, Schweiz Bernwald Personalberatung Vollzeit

    Unsere Mandantin ist ein Schweizer KMU, das sich in einer Nische im Pharmabereich erfolgreich etabliert hat. - In ihrem Auftrag suchen wir eine Persönlichkeit mit ausgeprägtem Verantwortungsbewusstsein als Regulatory Affairs Manager Pharma EU/CH (m/w/d). **IHRE AUFGABEN**: - Selbständiges Erstellen von CMC-Zulassungsdokumentationen - Termingerechte...

  • Associate Director, Global Regulatory Affairs Cmc

    vor 1 Woche

    Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as an Associate Director, Global Regulatory Affairs CMC - Marketed Products in our Zurich office. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an...

  • Regulatory Affairs Manager

    vor 2 Wochen

    Zurich, Schweiz ROCKEN Vollzeit

    Unser Kunde ermöglicht es Wissenschaftlern, bahnbrechende Entdeckungen zu machen und neue Anwendungen zu entwickeln, die die Lebensqualität des Menschen verbessern. Die leistungsstarken wissenschaftlichen Instrumente und hochwertige analytische und diagnostische Lösungen ermöglichen es Wissenschaftlern, Leben und Materialien auf molekularer, zellulärer...

  • Associate Director

    vor 2 Wochen

    Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    Job Description **People First** - At Takeda we are dedicated to improving the health and well-being of all people and bringing them the hope of a brighter future. It is our passion that transforms every job into meaningful action. **Our people are the heart of Takeda**. Looking for an interesting role where you can develop your career, work at a growing...

  • Sr. Manager, Eu Regulatory Lead

    vor 2 Wochen

    Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    **OBJECTIVE**: - Collaborates to define, develop and sometimes lead regional strategies to maximize regulatory approvals and patient access to meaningful medicines in alignment with program objectives - Provides regional strategic and tactical advice and guidance to teams to achieve timely and efficient conduct of development programs, while maintaining...

  • Qualitätsmanagement Medizinprodukte

    vor 1 Woche

    Zurich, Schweiz Marco Fuhrer Vollzeit

    Deine Aufgabe - Der Erfolg unserer Kunden bei der Markteinführung regulierter Produkte ist dein Antrieb. Als Senior Consultant bist Du ein Fachexperte, der interdisziplinäre Teams befähigt. Als inspirierende Führungspersönlichkeit schaffst Du Klarheit über regulatorische Anforderungen und hilfst deinen Kolleg:innen und Kund:innen, pragmatische...

  • Head of Epidemiology

    vor 1 Woche

    Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine?Join us as a** Head of Epidemiology** to be based in Zurich, Switzerland. **Here, you will be a vital contributor to our inspiring, bold mission.** **OBJECTIVES**: - Work with the Head of Strategic services in defining and implementing strategy...

  • Transaction Expert

    vor 2 Wochen

    Zurich, Schweiz Monterosa Services AG Vollzeit

    Monterosa is a Swiss independent financial services group with a global footprint, servicing approximately USD 15bn in assets. The Group was founded in 1996 and provides investment solutions for emerging and developed markets with 70+ employees in offices in Zurich, Dubai, Hong Kong, Singapore, Balzers (Liechtenstein) and Port Louis (Mauritius). To...

  • Head of Labor

    vor 1 Woche

    Zurich, Schweiz ABB Vollzeit

    **Head of Labor & Employment Law, Electrification Business (global)**: **Take your next career step at ABB with a global team that is energizing the transformation of society and industry to achieve a more productive, sustainable future. At ABB, we have the clear goal of driving diversity and inclusion across all dimensions: gender, LGBTQ+, abilities,...

Regulatory Affairs

vor 2 Wochen

Zurich, Schweiz Proclinical Vollzeit

Our client a global pharmaceutical company specializing in rare diseases, Nephrology and Cardiorenal therapeutic areas is looking to appoint a Regulatory Affairs Labelling manager in their Zurich offices. This is an excellent opportunity to gain global experience within RA labelling in a high performing team at a time when multiple new drug development programs are ongoing.

You will have significant experience within Regulatory Affairs in a pharmaceutical or biotechnology setting and exposure to labelling topics such as CCDS creation at the local or global level.

**Responsibilities**

  • Oversee arrangements and operation of external solution providers supporting GRAL activities.
  • Strategic Labelling.
  • Support CCDS creation & update in collaboration with other line functions by providing strategic input related to CCDS impact on labelling.
  • Leading GRA Labelling quality initiatives.
  • Support for CCDS implementation into local labelling including planning of roll-outs and strategical implementation into the local SmPC, PIL and labelling based on local regulation and management of deviations
  • Fulfil GRAL role and contribute to team activities as per mandated processes.
  • Support for responding to Health Authority questions on product information-related issues.
  • Interface with key stakeholders across the company.
  • Operational Labelling & Packaging (all regions).
  • Support and recommendations to GRA department and other departments on labelling related issues.
  • Maintenance of specific product labelling related information in department databases, systems and external processes (e.g. PSMF, XEVMPD, GLS, eDMS) and relevant tracking and planning systems (Trackwise).
  • Validation/record of product information documents, e.g. SmPC, PIL, packaging.

**Minimum Requirements**

  • University degree in Life Sciences or Pharmaceutical related fields.
  • Experience (5-8 years) working in regulatory affairs or supply chain specifically with labelling or packaging related responsibilities.
  • Excellent command of English - both spoken and written.
  • Expertise in the use of basic IT systems & tools.

**Preferred Requirements**

  • Higher university degree (Masters) in a relevant life sciences discipline, or specialised degree (Pharmacist).
  • Basic knowledge of drug development & labelling related issues.
  • Experience in pharmaceutical packaging implementation.
  • Familiarity with either pharmacovigilance concepts and practices, or with pharmaceutical supply chain processes.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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Regulatory